|Publication number||US8167581 B2|
|Application number||US 12/439,855|
|Publication date||May 1, 2012|
|Filing date||Sep 3, 2007|
|Priority date||Sep 4, 2006|
|Also published as||CN101511408A, EP2059283A2, US20100028170, WO2008029051A2, WO2008029051A3|
|Publication number||12439855, 439855, PCT/2007/51863, PCT/FR/2007/051863, PCT/FR/2007/51863, PCT/FR/7/051863, PCT/FR/7/51863, PCT/FR2007/051863, PCT/FR2007/51863, PCT/FR2007051863, PCT/FR200751863, PCT/FR7/051863, PCT/FR7/51863, PCT/FR7051863, PCT/FR751863, US 8167581 B2, US 8167581B2, US-B2-8167581, US8167581 B2, US8167581B2|
|Inventors||Niklaus Schneeberger, Véronique Vallet, Eric Chappel|
|Original Assignee||Debiotech Sa|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (16), Classifications (11), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The invention relates to a device for delivering a liquid, which device comprises a pump having an inlet duct suitable for being connected to a liquid reservoir and connected to an inlet control member of the pump, an outlet duct connected to an outlet control member of the pump, and a pumping portion having control means provided with a pumping membrane and a pumping chamber whose volume varies as a function of the deformation of the pumping membrane.
A siphoning effect represents a major problem for users of pumps for injecting liquid medication. If the pump or the liquid medication reservoir is situated at a height greater than the height of the place at which the injection is performed on the patient's body, the column of liquid in the injection line generates pressure that drives the liquid into the patient's body if the pump is not totally leaktight.
This situation often occurs for ambulatory injection pumps in which the pump contains the liquid medication reservoir, such as insulin pumps of the Continuous Subcutaneous Infusion of Insulin (CSII) type.
If one of the technical characteristics of the injection pump is that it uses a liquid medication reservoir that is of variable volume, a similar danger can occur when the reservoir is subjected to pressure. If the reservoir is situated inside a ventilated housing, as applies in pumps of the CSII type, and the ventilation system fails, such a pressure can occur.
In everyday life, that situation can occur if a user of such a type of pump goes swimming in the sea or in a swimming pool with that pump. When the patient comes out of the water, the membrane of the hydrophilic filter that protects the ventilation system from intake of water becomes blocked with salt coming from the seawater drying, and, in this situation, the air pressure at sea level of about 100 kilopascals (kPa) becomes trapped inside the housing. Subsequently, if the user is on board an airplane that climbs rapidly to its cruising altitude, at which the passenger compartment presents a predetermined pressure of about 72 kPa that is less than the value of the pressure at sea level, the pressure that is trapped inside the housing generates a thrust of 28 kPa driving the liquid medication from the reservoir towards the patient.
In an alternative situation in everyday life, a patient can place the pump at a level that is higher than the injection site. Depending on the length of the injection line and on the above-mentioned difference in level, suction is generated at the outlet of the pump by the siphon effect, due to the weight of the liquid. In this situation too, the liquid medication is driven by the pressure difference (or “siphon pressure” Psiph) towards the patient. In a typical situation, with an injection line that has a length of 1 meter (m) and with the medication having a density that is close to the density of water, said pressure differences can be as high as 10 kPa.
All of those situations present a danger due to a common factor that is the positive pressure difference (or “extra pressure”) between the liquid medication reservoir and the place of injection on the patient's body.
Usually, in order to mitigate that risk, “crack valves” are used in the zone in which the liquid flows, those valves being closed by default and opening at pressures greater than the maximum pressure difference that can be expected (EP 0 882 466). Unfortunately, for each injection, the pump must overcome the barrier set up by the crack valve. That solution thus suffers from the drawback of increasing the pressure required for performing the injection. That increase in injection pressure gives rise to degradation in the quantity of energy consumed and in the precision of the doses metered out by the pump. In addition, pressure differences between the reservoir and the outlet of the pump that are larger than those normally expected, can open the valve. Dimensioning of the valve is therefore critical.
In pumps of the positive displacement type (e.g. as in WO 90/15929 and in EP 183 957), it is possible to use an Anti-Siphon Valve (ASV) having three ports as an outlet control member of the pump itself. Such an anti-siphon valve (see 18 in FIG. 1 of WO 90/15929) is an integral part of the pump and it has an inlet channel 20 and an outlet channel 3 for the liquid and a reference port (reference pressure Pref that is the external pressure above the moving membrane 18 a). No liquid flow is possible from the reference port towards the outlet through such a valve. The liquid flow zone between the inlet and the outlet opens or closes firstly as a function of the pressure differences between the inlet port Pin and the reference port Pref and between the reference port Pref and the outlet Pout.
Depending on the dimensioning of said anti-siphon valves, the two pressure differences ΔPin=Pin−Pref and ΔPout=Pref−Pout act simultaneously on the anti-siphon valve but can have different magnitudes for opening the flow zone, as is shown diagrammatically in
In order to explain how anti-siphon valves operate, firstly consideration is given below to the situation in which the inlet pressure is in equilibrium with the reference pressure and ΔPin is thus equal to zero. This particular situation corresponds to the horizontal axis of
In another particular situation that corresponds to the vertical axis, if the reference pressure is in equilibrium with the outlet pressure and ΔPout is thus equal to zero, the valve opens when the pressure difference ΔPin is greater than Tin (inlet pressure threshold), which is another set value that is intrinsic to the anti-siphon valve.
It is thus either when ΔPin increases, or when ΔPout decreases (or when both occur at the same time) that the anti-siphon valve goes from the closed position to the open position, and vice versa.
The curve that is representative of the opening and closure principle for opening and closure of such anti-siphon valves can be described as the function f(ΔPout), and it can be understood that the valve is open under the conditions (ΔPin, ΔPout) if ΔPin>f(ΔPout). It can also be understood that the pressure thresholds Tout and Tin are point of intersection of that function with the axes.
In all of the cases of curves representing the f(ΔPout) relationship, regardless of the starting point (ΔPin, ΔPout) representing a given situation of the valve:
Such anti-siphon valves, whose opening and closure principle is shown in
In an ideal configuration, the pressure Pret of the reference port or of the reference chamber is in equilibrium with the pressure of the liquid in the liquid medication reservoir Pres, i.e. Pres=Pref, and the valve opens only for pressure differences that are sufficiently small ΔPout=Pres−Pout. In this ideal configuration, the additional pressure differences between the liquid reservoir Pres and the outlet of the injection pump enable the anti-siphon valve (ASV) to close, either due to the arrangement of the pressures inside the pump or else due to a column of liquid sucking the liquid from the outlet of the pump.
In such systems (described, for example, in WO 90/15929 and in EP 183 957) in which the anti-siphon valve is placed at the outlet of the pump as an outlet control member of the pump itself, provision is made so that Pres=Pref. In the above-described disaster scenario, if the salt coming from the swimming water blocks the ventilation of the housing containing the pump, the air pressure at sea level of about 100 kPa becomes trapped inside the housing as reference pressure Pref, so that, when the user is inside an airplane passenger compartment in which the pressure is 72 kPa, the extra pressure of 28 kPa causes the inlet control member (valve 16 in FIG. 1 of WO 90/15929) to open, and the pressure inside the reservoir of 100 kPa comes into equilibrium with the pressure at the inlet of the anti-siphon valve (zone 20 in FIG. 1 of WO 90/15929) and the following situation is reached: Pin=Pres=Pref and therefore ΔPin=0 and ΔPout=28 kPa. Thus, the anti-siphon valve does indeed close if Tout<28 kPa. If, for any reason, the pressure difference ΔPout is even greater than 28 kPa, the anti-siphon valve remains closed and thus performs its safety function.
This is the opposite of what happens in a valve for which an additional pressure difference makes it possible to open the valve and an additional negative pressure difference makes it possible to close the valve.
Therefore, such an anti-siphon valve can be designed with a start-of-flow pressure (or “outlet pressure threshold”) Tout that is smaller than the expected pressure differences and thus that is smaller than the start-of-flow pressure (or “inlet pressure threshold”) Tin of a simple two-port valve.
Micropumps, such as those used in EP 183 957, present advantages for injecting liquid medication, including the advantages of having high precision and small pumping volume. Using micro-machining technology, it is also possible to fabricate micropumps that have a compression ratio that is sufficiently high for them to be self-priming, in spite of their small pumping volume. This is obtained by reducing all of the volumes in the pump proportionally to the pumping volume. Unfortunately, in micro-machining, the valves are made of hard materials (e.g. silicon) because it is not possible to incorporate soft materials into micro-machining methods, in particular for the moving portion and/or the seat of the valve.
Therefore, that type of pump is extremely sensitive to dust and to particles that can lodge themselves between the contact surfaces of the valve that are made of hard materials, thereby preventing any possibility of leaktight closure. Non-leaktight valves make dangerous leaks possible if there is a pressure difference between the liquid medication reservoir and the place of injection.
For example, in the above-discussed disaster situation, even though the pressure difference ΔPout=28 kPa causes the valve to close, if there are leaks due to particles, that pressure difference nevertheless drives the liquid towards the patient, and the safety function is not guaranteed.
An object of the present invention, is to provide a device that makes it possible to overcome the drawbacks of the prior art, and in particular that offers the possibility of combining the advantages of self-priming micropumps with the advantages of anti-siphon valves that are less sensitive to particles.
To this end, according to the present invention, the above-presented device for delivering a liquid is characterized in that it further comprises an anti-siphon valve external to the pump and having an inlet channel connected to the outlet duct of the pump, and an outlet channel, between which channels a seat and a moving member are disposed that are suitable for co-operating together and that define, between the inlet channel and the outlet channel of the valve, a leaktight liquid flow zone, said moving member being suitable for going from an opening position making it possible for liquid to flow through said flow zone, to a closure position in which the moving member comes into contact with the seat of the valve and prevents any flow through said flow zone, said moving member being subjected to the pressure of a reference chamber that is not in fluid communication with the outlet channel.
In this way, it can be understood that, by combining a micropump with an external valve, it is possible to maintain the precision of the micropump while broadening the range of possible valve types that can be used.
An anti-siphon valve that is external to the pump can advantageously be obtained using techniques different from micro-machining techniques, and thus, for example, for forming anti-siphon valves of the macroscopic type that are less sensitive to particles.
In a preferred feature, the seat and/or the moving member of said anti-siphon valve is made of a soft material, e.g. of elastomer, in particular of silicone or of natural rubber, or indeed of synthetic rubber.
In this manner, by using a soft external valve, it is possible to maintain the precision of the micropump and the tolerance to particles is improved, and thus the risks of the valve leaking in the closed position are reduced compared with such risks in a valve in which the closure contact zones are made of hard materials (e.g. materials used for manufacture by micro-machining techniques, such as silicon, metal oxides, etc.).
Thus, in this way, it is possible to combine the advantages of a pump of small size that can be micro-machined with the advantages of soft valves that are tolerant to particles.
In practice, such an external valve presents a size that is larger than the size of a micro-machined valve, and thus also dead volume that is larger. During the self-priming, the micropump must compress the gas throughout said volume until the opening threshold Tin of the external valve is reached in order for said gas to penetrate into said valve and cause the liquid to advance. The dead volume and the opening threshold (or inlet pressure threshold) Tin of said external valve thus influence the self-priming properties of the micropump and thus of the entire system.
Preferably, the moving member of the anti-siphon valve is caused to go between its closure position and its opening position at least by the pressure (Pref) prevailing in the reference chamber.
In fact, the moving member of the anti-siphon valve is caused to open by two pressure differences, namely ΔPin=Pin−Pref and ΔPout=Pref−Pout.
In a preferred particular embodiment, the external valve is open by default, and thus the predetermined outlet pressure threshold Tout is positive and the predetermined inlet pressure threshold Tin is negative. This preferred embodiment is shown in
In which case, the self-priming capacity of the micropump is no longer affected by the external anti-siphon valve because it is not necessary to compress the gas at the outlet of the of pump in order to exceed the inlet pressure threshold Sin and cause the gas to enter the anti-siphon valve.
In another preferred feature, the pump is a micropump, i.e. a micro-mechanical pump manufactured by micro-machining techniques.
If said outlet channel of the anti-siphon valve is connected to an injection line (which, for example, is terminated by a injection catheter), advantageously said predetermined closure pressure threshold (Tout) is less than the inverse of the siphon pressure (−Psiph) prevailing in the valve, if said injection line is disposed vertically with the distal end (the end that is close to the patient) downwards.
In which case, this means that the following inequality is satisfied:
0<T out <−P siph =L×G×D
where L is the length of the injection line, G is the gravitational constant, and D is the density of the fluid.
In another feature of the present invention, said reference pressure (Pref) is substantially equal to the pressure prevailing in the inlet duct of the pump, when the pump is at rest (inactive) or in the equilibrium state.
As regards, in particular, the structure of the device, one or more of the following features can be implemented:
Other advantages and characteristics of the invention appear on reading the following description given by way of example and with reference to the accompanying drawings, in which:
In the first and second embodiments that are described below, the device of the invention can include a pump 1 of the self-priming micro-mechanical pump or micropump type as presented in Document EP 739 451 that is made essentially of silicon and of glass.
A pump 1 is chosen that has a compression ratio that is sufficiently high to exceed the opening pressure of the internal valves serving as liquid inlet and outlet control members 17, 19 for a compressible fluid such as air.
The inlet duct 8 is suitable for being connected to a liquid reservoir 6 which, in the embodiment shown, is an integral part of the device, but which could be in a separable form.
The device also includes an external anti-siphon valve 4 that is separate from the pump 1. The inlet channel 3 of the valve 4 is connected to the outlet duct 2 of the pump 1.
A valve 4 is chosen in which both of or at least one of the elements constituted by the moving portion 11 and by the seat 11 a that faces said moving portion are/is made of a soft material. In this way, the anti-siphon valve 4 remains leaktight in its closure position in spite of the presence of dust and of particles.
The term “soft material” is used to mean a material that is not rigid, and whose type and/or thickness make(s) the moving portion 11 elastic and/or pliable so as to deform and absorb variations in surface states due to the presence of dust and of particles, of size of the order of in the range a fraction of one micrometer to a few micrometers.
For example, said soft material is an elastomer polymer such as silicone, polybutadiene, synthetic rubber of the Viton (registered trademark) type, ethylene-propylene rubber, or natural rubber.
In the example shown, the moving portion 11 is a flexible film of polymer such as polyvinyl chloride, polyethylene, polycarbonate, polyamide, or polyolefin, having a thickness lying in the range 5 micrometers to 200 micrometers.
In the example shown, the valve 4 is formed in a housing 10, e.g. made of a rigid plastics material, in which the following are formed:
The film constituting the moving member 11 is fastened in leaktight manner to the surface of the valve body 10, all around the seat 11 a of the valve 4.
By means of the moving member 11, the inlet channel 3, the outlet channel 7, and the seat 11 a of the valve define a leaktight liquid flow zone that is situated downstream from the pump 1 and upstream from the patient (not shown).
That face of the moving portion 11 that faces away from the seat 11 a is in contact with a reference chamber 5 whose pressure Pref influences the position (open or closed) of the valve 4, as a function of the value of the pressure Pout prevailing in the outlet channel 7 of the valve 4.
In the example shown, the reservoir 6 has been formed in a reservoir body 13 defining a cavity that can be filled with the liquid medication, which cavity is closed by a reservoir wall 14. In this example, the reservoir wall 14 is a moving wall and is formed of a flexible film of polymer, fastened in leaktight manner to the surface of the reservoir body 13.
The reservoir 6 is designed to be filled with liquid, without any gas being present in order to avoid any risk of gas arriving in the pump 1. In order to enable the volume of the reservoir 6 to vary while it is being filled or while it is emptying, the moving reservoir wall 14 is formed by a film that can deform (a flexible film) without it being elastic or extensible. To this end, it is possible to use a polymer such as polyvinyl chloride, polyethylene, polycarbonate, polyamide, or polyolefin, of a thickness lying in the range 5 micrometers to 200 micrometers.
For reasons of simplicity, as can be seen in
For this single film 11/14, it is possible to choose a flexible film made of a material such as those presented above. It is also possible to provide a film 11/14 formed of a superposition of at least two layers, namely:
A cover 15 overlies the stationary body 10/13 while extending above the reservoir 6 and the valve 4, the pump 1 being situated on another face of the stationary body 10/13.
The cover 15 is not mounted in leaktight manner on the stationary body 10/13 but it should prevent any liquid from entering the device, in particular into the cavity 16 of the cover 15. To this end, ventilation (not shown) is provided between the outside of the cover 15 and the cavity 16 of the cover 15, with a hydrophobic filter.
Thus, it can be understood that the external air pressure (external pressure) outside the device (outside the cover 15) can penetrate into the cavity 16 of the cover 15. In this way, by means of the flexibility of the film constituting the moving reservoir wall 14 and the moving member 11 of the valve 4, said external pressure is also the pressure that is exerted inside the reservoir 6 (liquid pressure Pres) and inside the reference chamber 5 (gas pressure Pref) of the valve 4.
By means of the configuration presented above, the (gas) pressure Pref of the reference chamber 5 is thus the same as the liquid pressure (Pres) prevailing in the liquid medication reservoir 6.
A preferred particular embodiment in which the external valve is open by default is shown in its operating mode in
The valve 4 then has an outlet pressure threshold Tout that is positive, i.e. it is open if the pressure Pout prevailing in the outlet channel 7 of the valve 4 is equal to or greater than the pressure Pref prevailing in the reference chamber 5 minus the outlet pressure threshold Tout of the valve 4 (Pout≧Pref−Tout), when the inlet pressure Pin is in equilibrium with the reference pressure Pref.
Conversely, i.e. when the pressure Pout prevailing in the outlet channel 7 of the valve 4 is less than the pressure Pref prevailing in the reference chamber 5 by a certain difference (outlet pressure threshold Tout of the valve 4), or Pout<Pref−Tout, and when the inlet pressure Pin is in equilibrium with the reference pressure Pref, the valve is in the closed position.
In this preferred particular embodiment, the valve 4 presents an inlet pressure threshold Tin of negative value: when the outlet pressure Pout is in equilibrium with the reference pressure Pref, then the valve is open if ΔPin≧Tin, and the valve is closed if ΔPin<Tin.
In this particular situation, in which the anti-siphon valve is open in the equilibrium position, as shown in
Thus, for example, if the ventilation is blocked, as in the above-described situation, due to a swim in seawater, the pressure enclosed in the cavity 16 of the cover 15 is about 100 kPa or greater than 100 kPa. This pressure acts on the pressures in the liquid reservoir 6 (Pres) and in the reference chamber 5 (Pref) of the anti-siphon valve 4, which pressures then take said value of 100 kPa. If the valves of the micropump are not sufficiently leaktight, the same pressure establishes itself at the inlet (channel 3) of the anti-siphon valve 4 (Pin=100 kPa). When the user then travels by airplane and the airplane climbs to its cruising altitude, the pressure inside the passenger compartment of the airplane, and thus at the outlet 7 of the anti-siphon valve 4, is about 72 kPa. There is thus a pressure difference ΔPout of 28 kPa between the reference chamber 5 and the outlet channel 7 of the anti-siphon valve 4. If consideration is given to the pressure Pin in the inlet channel 3 of the valve 4 at the time the airplane climbs, if the valves of the micropump 1 are not fully leaktight, Pin remains at the pressure value in the reference chamber 5 (Pref), i.e. Pin=Pref=100 kPa, so that ΔPin=0 (the current location is on the vertical y-axis in
In this way, it can be understood that the valve 4 closes again, and performs its anti-siphon function when the pressure (Pres) of the reservoir 6 is greater than the pressure of the place of injection on the patient's body, thereby preventing any leakage of liquid towards the patient that is not caused by the pump 1 operating.
It can also be understood that such an anti-siphon valve can perform its function even if it is contaminated by particles of small size because the closure remains leaktight by means of soft or pliable materials being used.
In addition, in most cases, a valve is formed that has performance as shown in the diagrams of
In which case, the anti-siphon valve presents an inlet pressure threshold Tin of negative value and an outlet pressure threshold Tout of positive value, so that the point O (where ΔPin=ΔPout=0) is situated in the open zone: it is then said that the valve is open by default.
Thus, the valve 4 is open by default so that it therefore does not contribute to the dead volume of gas to be compressed in the liquid delivery device of the present invention. Therefore, it does not affect the self-priming performance of the pump 1.
In the second embodiment shown in
In the second embodiment, which might be said to be “nested” in shape, the film forming the moving member 11′ of the valve 4 is mounted in leaktight manner on the bottom wall of the reservoir 6 so that it is said reservoir that constitutes the reference chamber 5.
A structure is thus obtained that is more compact, and equilibrium between the pressure of the reservoir Pres and the reference pressure Pref is guaranteed by construction. However, operation remains the same.
For example, in the blocked-ventilation situation, the same pressure of 100 kPa is enclosed under the cover 15 and acts on the liquid in the reservoir 6 and thus also on the reference chamber 5 of the anti-siphon valve 4. If the valves of the micropump 1 are not fully leaktight, said pressure of 100 kPa then acts on the outlet pressure Pout of the valve 4 and on the inlet pressure Pin of the valve 4. Then, when the user is inside an airplane at its cruising altitude, the pressure in the passenger compartment of the airplane is 72 kPa. This scenario has the following consequences:
Thus, in the two embodiments shown in
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|U.S. Classification||417/278, 417/279, 604/153|
|International Classification||A61M1/00, F04B49/10|
|Cooperative Classification||A61M2005/14264, A61M5/14244, A61M5/16881, A61M2205/0244|
|European Classification||A61M5/142P, A61M5/168F1|
|Mar 4, 2009||AS||Assignment|
Owner name: DEBOITECH SA,SWITZERLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SCHNEEBERGER, NIKLAUS;VALLET, VERONIQUE;CHAPPEL, ERIC;REEL/FRAME:022341/0676
Effective date: 20090122
Owner name: DEBOITECH SA, SWITZERLAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SCHNEEBERGER, NIKLAUS;VALLET, VERONIQUE;CHAPPEL, ERIC;REEL/FRAME:022341/0676
Effective date: 20090122
|Aug 21, 2012||CC||Certificate of correction|
|Dec 11, 2015||REMI||Maintenance fee reminder mailed|